CENTER FOR DRUG EVALUATION AND RESEARCH

DIVISION of
DRUG INFORMATION

Your source for the latest drug information. Know the moment it happens.

​

FDA Publishes Draft Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This draft guidance replaces the May 2003 guidance entitled “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling,” and when finalized, will represent FDA’s current thinking.

Liver disease can lead to changes in a drug’s pharmacokinetics to a degree necessitating different recommendations for use of the drug in patients with hepatic impairment. This draft guidance is intended to provide recommendations to sponsors and applicants who plan to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, pharmacodynamics of a drug, including therapeutic biological products.

FDA seeks feedback on this draft guidance document. To ensure the FDA considers your comment, please submit your comments by Dec 1, 2026, at 11:59 PM EST to the docket (Docket No. FDA-2026-D-8693).

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov.